ISSUE: The European Union (EU) Medical Devices Regulation 2017/745 (MDR) became effective in May 2021 with a key aim to improve clinical evidence generation. The legislative proposal for regulation of health technology assessment (HTA) in the EU appears to be moving forward with the hope of supporting market access processes for innovative technologies by centralizing clinical assessments. These regulations foresee a key role for expert panels to inform Notified Bodies (NBs) during conformity assessment for CE mark and in early dialogue for HTA for coverage decisions, but how and whether they should be combined remains an open question.

OVERVIEW: The panel will debate the benefits and intended/unintended consequences of instituting a unique expert panel for CE mark and HTA. They will address how such a proposal might affect the roles of NBs and various stakeholders, including European and national regulatory agencies, HTA bodies, payers, policymakers, manufacturers, patients, and if and how a unique panel might negatively/positively affect timely, equal access to safe, effective innovation. Paul Piscoi (10’) will present the EU policy viewpoint regarding cooperation on HTA, proposed EU HTA Regulation and MDR. Sabina Hoekstra (10’) will discuss NB interaction with EU and HTA bodies, stakeholders and manufacturers and if and how a unique CE Mark/HTA expert panel might fit in the current scenario. Andrea Rappagliosi (10’) will discuss industry’s perspective on pathways to CE Mark and reimbursement under MDR and proposed EU HTA Regulation, discussing interactions with NBs and stakeholders in preparing clinical documentation for CE Mark/HTA. 10’ will be allocated to the introduction of the panel issue and 20’ will be allotted to discussion. The entire Medical Device and HTA ecosystem would benefit from attending.